DIATOR-Diabetes Intervention With Atorvastatin

Phase 1

Terminated

• Conditions: Type 1 Diabetes
• Interventions: Drug: atorvastatin matching placebo; Drug: Atorvastatin

• Registration Number: NCT00974740
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

Brief Summary

Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated C-peptide levels.

Detailed Description

The objectives of this study were as follows:

* To assess the effect of atorvastatin on pancreatic beta-cell function as measured by C-peptide after a liquid mixed meal stimulation in patients with newly diagnosed type 1 diabetes,

* To assess the effect on metabolic control as measured by HbA1c and insulin requirements,

* To assess safety and tolerability of atorvastatin in subjects with newly diagnosed type 1 diabetes,

* To assess the effect on risk factors of diabetic complications as indicated by changes in lipids and CRP, and

* To assess the effect on systemic immune abnormalities as measured by effects on beta-cell autoantibodies, blood cytokines and chemokines on protein and transcriptional level.

Study duration: 18 months

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2008-01
• Study Completion: 2009-03
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
• Age 18 to 39 years, inclusive
• Male patient or female patient using adequate contraceptive methods
• Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA

Exclusion Criteria

• History of a malignancy
• Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated more than ten percent above the upper limit of normal, elevation of AST or ALT more than 3 times the upper limit of normal
• Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
• Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
• Pregnant or nursing women or women intending to become pregnant
• Known or suspected allergy to atorvastatin or any component of thr trial product
• Known myopathy, myalgia or myositis with a serum-CPK above 3 times the upper limit of normal
• Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
• Any significant laboratory abnormality
• A serum LDL-cholesterol above 150 mg/dL at time of screening
• Unwillingness to comply with study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atorvastatin matching placebo	atorvastatin matching placebo	atorvastatin matching placebo
atorvastatin	Atorvastatin	40 mg atorvastatin for 4 weeks (run-in period), then 80 mg atorvastatin, total treatment period was 18 months

Primary Outcome Measures

Name	Time	Method
C-peptide after a liquid mixed meal stimulation	at randomization, after 12 months, and after 18 months of treatment

Secondary Outcome Measures

Name	Time	Method
HbA1c	at randomization, after 6, 12, and 18 months of treatment
serum lipids	at randomization, and after 3, 6, 12, and 18 months of treatment
insulin dose	at randomization, and after 3, 6, 12, and 18 months of treatment
adverse events	at randomization, and after 3, 6, 12, and 18 months of treatment
plasma CRP	at randomization, and after 3, 12, and 18 months of treatment

Trial Locations

Locations (12)

Helios Klinikum Emil von Behring; 🇩🇪 Berlin, Germany

Praxis Dr. Gerhard Willms; 🇩🇪 Leverkusen, Germany

Praxisklinik Leipzig; 🇩🇪 Leipzig, Germany

Diabetologische Schwerpunktpraxis, Angiologie; 🇩🇪 Münster, Germany

DDZ Deutsches Diabetes Zentrum; 🇩🇪 Düsseldorf, Germany

Praxis Dr. Werner Stürmer; 🇩🇪 Würzburg, Germany

Diabetes-Zentrum Mergentheim; 🇩🇪 Bad Mergentheim, Germany

Praxis Dr. Friedhelm Schmitten; 🇩🇪 Bestwig-Ramsbeck, Germany

St. Josefs Krankenhaus; 🇩🇪 Heidelberg, Germany

Praxis Dr. Heinz-Georg Ley; 🇩🇪 Marl, Germany

Gemeinschaftskrankenhaus Havelhöhe; 🇩🇪 Berlin, Germany

St. Antonius Krankenhaus, Med. Klinik; 🇩🇪 Köln, Germany